U.S. patent application number 16/782477 was filed with the patent office on 2021-01-21 for ablation device with articulated imaging transducer.
The applicant listed for this patent is Gynesonics, Inc.. Invention is credited to Robert K. Deckman, Craig Gerbi, Jessica Grossman, Michael A. Munrow, Brian Placek.
Application Number | 20210015450 16/782477 |
Document ID | / |
Family ID | 1000005131604 |
Filed Date | 2021-01-21 |
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United States Patent
Application |
20210015450 |
Kind Code |
A1 |
Deckman; Robert K. ; et
al. |
January 21, 2021 |
ABLATION DEVICE WITH ARTICULATED IMAGING TRANSDUCER
Abstract
A system for imaging and treating tissue comprises a probe
having a deflectable distal tip for carrying an imaging array and a
delivery needle for advancement within a field of view of the
imaging array. Optionally, the needle will carry a plurality of
tines which may be selectively radially deployed from the needle.
The imaging array will preferably be provided in a separate,
removable component.
Inventors: |
Deckman; Robert K.; (San
Bruno, CA) ; Placek; Brian; (Manhattan, KS) ;
Munrow; Michael A.; (Belmont, CA) ; Gerbi; Craig;
(Mountain View, CA) ; Grossman; Jessica;
(Covington, KY) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Gynesonics, Inc. |
Redwood City |
CA |
US |
|
|
Family ID: |
1000005131604 |
Appl. No.: |
16/782477 |
Filed: |
February 5, 2020 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14989732 |
Jan 6, 2016 |
10610197 |
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16782477 |
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13484076 |
May 30, 2012 |
10595819 |
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14989732 |
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13023383 |
Feb 8, 2011 |
8206300 |
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13484076 |
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PCT/US09/54956 |
Aug 25, 2009 |
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13023383 |
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12198861 |
Aug 26, 2008 |
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PCT/US09/54956 |
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12973587 |
Dec 20, 2010 |
8506485 |
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13484076 |
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11564164 |
Nov 28, 2006 |
7874986 |
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12973587 |
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11409496 |
Apr 20, 2006 |
7815571 |
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11564164 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2017/3413 20130101;
A61B 2018/0016 20130101; A61B 18/1485 20130101; A61B 2018/00577
20130101; A61B 8/0841 20130101; A61B 2018/00559 20130101; A61B
2018/1425 20130101; A61B 2018/143 20130101; A61B 2090/3782
20160201; A61B 8/12 20130101; A61B 8/4461 20130101; A61B 2018/1432
20130101; A61B 8/445 20130101; A61B 2090/3784 20160201; A61B
2018/1475 20130101 |
International
Class: |
A61B 8/12 20060101
A61B008/12; A61B 8/08 20060101 A61B008/08; A61B 8/00 20060101
A61B008/00; A61B 18/14 20060101 A61B018/14 |
Claims
1.-26. (canceled)
27. A method of treating a uterine fibroid, the method comprising:
transcervically introducing into a uterus a rigid shaft comprising
a tip attached to a distal end of the shaft, the tip including an
ultrasound transducer; deflecting the tip to reposition a field of
view of the ultrasound transducer; locating the uterine fibroid
using the ultrasound transducer; advancing a needle into the
uterine fibroid from a needle guide delivered transcervically into
the uterus; advancing a plurality of tines from the needle into the
uterine fibroid; observing the needle, the plurality of tines, and
the uterine fibroid using the ultrasound transducer; and adjusting
a distance of tine deployment based on a size of the uterine
fibroid.
28. The method of claim 27, wherein locating the uterine fibroid
comprises manually rotating and/or torquing the rigid shaft to scan
the uterus with the ultrasound transducer.
29. The method of claim 27, further comprising delivering
radiofrequency energy to the uterine fibroid through the plurality
of tines.
30. A method of treating a uterine fibroid, the method comprising:
introducing into a uterus a rigid shaft comprising a tip attached
to a distal end of the shaft, the tip including an imager;
deflecting the tip to reposition a field of view of the imager;
locating the uterine fibroid using the imager; advancing a needle
into the uterine fibroid; advancing a plurality of tines from the
needle into the fibroid; observing the needle, the plurality of
tines, and the uterine fibroid using the imager; and adjusting a
distance of tine deployment based on a size of the uterine
fibroid.
31. The method of claim 30, wherein introducing the rigid shaft
comprises transcervically introducing the rigid shaft into the
uterus.
32. The method of claim 30, wherein longitudinally advancing the
needle into the uterine fibroid comprises transcervically inserting
the needle.
33. The method of claim 30, wherein locating the uterine fibroid
comprises manually rotating and/or torquing the rigid shaft to scan
the uterus with the imager.
34. The method of claim 30, further comprising delivering energy to
the uterine fibroid through the plurality of tines.
35. A method of treating a uterine fibroid, the method comprising:
introducing into a uterus a rigid shaft comprising a tip attached
to a distal end of the shaft, the tip including an imager;
deflecting the tip to reposition a field of view of the imager;
locating the uterine fibroid using the imager; advancing a needle
into the uterine fibroid; and observing the needle and the uterine
fibroid using the imager.
36. The method of claim 35, wherein introducing the rigid shaft
comprises transcervically introducing the rigid shaft into the
uterus.
37. The method of claim 35, wherein advancing the needle into the
uterine fibroid comprises transcervically inserting the needle.
38. The method of claim 35, wherein advancing the needle into the
uterine fibroid comprises inserting the needle from a needle
guide.
39. The method of claim 35, wherein the imager comprises an
ultrasound transducer.
40. The method of claim 35, wherein locating the uterine fibroid
comprises manually rotating and/or torquing the rigid shaft to scan
the uterus with the imager.
41. The method of claim 35, further comprising, after advancing the
needle, advancing a plurality of tines from the needle into the
fibroid.
42. The method of claim 41, wherein observing the needle and the
fibroid comprises observing the plurality of tines.
43. The method of claim 41, further comprising adjusting a distance
of tine deployment based on a size of the uterine fibroid.
44. The method of claim 35, further comprising delivering energy to
the uterine fibroid through the needle.
45. The method of claim 44, wherein the energy is radiofrequency
energy.
46. The method of claim 35, wherein advancing the needle comprises
advancing a button on a handle.
47. The method of claim 35, wherein the needle comprises a curved
needle.
48. The method of claim 35, wherein locating the uterine fibroid
using the imager comprises inserting the imager through a sheath.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 14/989,732, filed Jan. 6, 2016, now U.S. Pat.
No. ______; which is a continuation of U.S. patent application Ser.
No. 13/484,076, filed May 30, 2012, now U.S. Pat. No.______; which
is a continuation-in-part of U.S. patent application Ser. No.
13/023,383, filed Feb. 8, 2011, now U.S. Pat. No. 8,206,300; which
is a continuation of PCT Application No. PCT/US09/54956, filed Aug.
25, 2009; which is a continuation-in-part of U.S. patent
application Ser. No. 12/198,861, filed on Aug. 26, 2008; U.S.
patent application Ser. No. 13/484,076 is also a
continuation-in-part of U.S. patent application Ser. No.
12/973,587, filed Dec. 20, 2010, now U.S. Pat. No. 8,506,485; which
is a continuation of U.S. patent application Ser. No. 11/564,164,
filed Nov. 28, 2006, now U.S. Pat. No. 7,874,986; which is a
continuation-in-part of application Ser. No. 11/409,496, filed Apr.
20, 2006, now U.S. Pat. No. 7,815,571; the full disclosures of
which are incorporated herein by reference.
BACKGROUND OF THE INVENTION
1. Field of the Invention
[0002] The present invention relates generally to medical devices
and methods. More particularly, the present invention relates to an
imaging and therapy device having a deployable treatment needle or
needles and a pivotal imaging array.
[0003] Uterine fibroids are benign tumors in the uterine wall and
are the most common tumor of the female pelvis. Fibroids afflict up
to 30% of women of childbearing age and can cause significant
symptoms including discomfort, pelvic pain, mennorhagia (excessive
bleeding), anemia, infertility, and miscarriage. While fibroids may
be located in the muscle (intramural), adjacent to the endometrium
(submucosal), or in the outer layer of the uterus (subserosal), and
can grow up to several centimeters in diameter.
[0004] Current treatments for fibroids include both pharmaceutical
and surgical intervention. Pharmaceutical treatments include the
administration of NSAIDS, estrogen-progesterone combinations, and
the like. Medications, however, are generally ineffective and are
palliative rather than curative. Surgical interventions include
myomectomy, where fibroids are removed in an open surgical
procedure requiring laparotomy and general anesthesia, and
hysterectomy, involving complete surgical removal of the uterus.
Both these procedures are long and have significant blood loss.
[0005] As improvements over open surgical procedures, several
minimally invasive procedures have been developed. Laparoscopic
myomectomy is a laparoscopic procedure requiring highly skilled
laparoscopic gynecologists. Uterine artery embolization relies on
blocking the uterine artery supplying blood to the fibroid by
injecting small particles. While sometimes effective, common
complications of arterial embolization include infection, premature
menopause, and severe pelvic pain. A third approach relies on
complete endometrial ablation, which is generally effective for
treating bleeding but less reliable for treating fibroids.
[0006] More recently, and of particular interest to the present
invention, the use of radiofrequency needles and other ablation
elements for treating individual fibroids via a transvaginal
approach has been proposed. As described, for example, in U.S.
Patent Publications 2006/0189972; 2007/0179380; and 2008/0033493,
each of which is commonly assigned with the present application, a
probe carrying a curved needle is used to treat individual
fibroids. The probe carries on-board ultrasonic or other imaging so
that the needle can be guided into the fibroid under direct
observation. While highly effective in many cases, accurate
advancement of a curved needle into a fibroid can be problematic.
Moreover, use of a single needle does not always deliver sufficient
energy to fully ablate relatively large fibroids.
[0007] For these reasons, it would be desirable to provide
alternative devices and methods for treating, ablating, or removing
uterine fibroids and other tissue masses. It would be particularly
desirable if such methods and devices were able to treat uterine
fibroids which are large, difficult to penetrate, or which
otherwise resist treatment with curved and laterally deployed
needles. At least some of these objectives will be met by the
inventions described below.
2. Brief Description of the Background Art
[0008] The following US Patent Publications discussed above are
relevant to the present invention: 2006/0189972; 2007/0179380; and
2008/0033493. See also US Patent Publication 2007/0249936. The
disclosures of each of these applications is incorporated herein by
reference.
BRIEF SUMMARY OF THE INVENTION
[0009] The present invention provides apparatus and methods for
imaging and treating fibroids and other tumors and tissue masses
located in the walls of a uterus or other body cavity. The
apparatus and systems comprise a straight shaft having a distal end
and a proximal end. A delivery needle, preferably straight, is
reciprocatably coupled to the shaft, typically being mounted in a
straight lumen in the shaft, so that a tissue-penetrating tip of
the needle can be distally advanced from the shaft along an axial
path. The delivery needle may carry tines forming a needle array,
deployable from within the delivery needle. A tip or other
structure is pivotally attached to the distal end of the shaft and
is moveable between a position parallel to the axial path and a
position at an acute or right angle relative to the axial path. The
pivotable tip carries or comprises an ultrasonic imaging array, and
the tip can be oriented to align a field of view of the imaging
array with the needle as the needle is advanced along the axial
path.
[0010] The combination of a straight shaft, delivery needle, and
pivotally attached tip or imaging array has a number of advantages.
The straight shaft and needle can be advanced with precision into
tissue surrounding the body cavity, where the needle can be made
sufficiently strong to resist unwanted deflection of the type which
could occur with other needle configurations. The use of a delivery
needle and shaft also enables and facilitates the deployment of a
needle array, including a plurality of tines, from the delivery
needle to increase the volume of tissue being treated with the
needle array. The pivotable imaging array allows straightening of
the imaging array to provide a low profile for introduction through
the cervix into the uterus, while also allowing reorientation to
cover a wide range of viewing fields after entering the uterus or
other body cavity to permit locating fibroids and other tumors and
to further follow the advance of the needle array into the fibroids
or other tumors. It should be noted that in the preferred
embodiment, the delivery needle is for delivery only, and does not
provide treatment. In alternative embodiments, the delivery needle
may be used for treatment. The pivotable tip further allows the
effective field of view of the ultrasound image to be increased by
pivoting the tip, which has the effect of sweeping the ultrasound
image. The tip may be pivoted to enhance the view of the delivery
needle and/or the needle array, including tines.
[0011] In a preferred embodiment, an imaging and therapeutic
delivery system includes a straight shaft having a distal end and a
proximal end and a straight needle reciprocatably coupled to the
shaft so that a tissue-penetrating tip on the needle can be
distally advanced from the shaft along an axial path and a tip
pivotally attached to the distal end of the shaft and movable
between a position parallel to the axial path and a position at an
acute or right angle relative to the axial path. An ultrasonic
imaging array is carried by the pivotally attached tip, wherein the
tip can be oriented to align a field of view of the imaging array
with the needle as it is advanced along the axial path so as to
sweep the ultrasound field of view relative to the needle and
anatomy to be imaged. The tip is offset from the axial path of the
needle.
[0012] In certain preferred embodiments, an imaging and therapeutic
delivery system includes a straight shaft having a distal end and a
proximal end. A needle is reciprocatably coupled to the shaft so
that a tissue-penetrating tip on the needle can be distally
advanced from the shaft along an axial path, said needle exiting
said shaft at an angle of 0 degrees relative to said shaft. A tip
is pivotally attached to the distal end of the shaft and movable
between a position parallel to the axial path and a position at an
acute or right angle relative to the axial path. An ultrasonic
imaging array is carried by the pivotally attached tip, wherein the
tip can be oriented to align a field of view of the imaging array
with the needle as the needle is advanced along the axial path so
as to sweep the ultrasound field of view relative to the needle and
anatomy to be imaged.
[0013] In the preferred embodiment, the imaging array will be
formed on an imaging core, where the imaging core is removably
positionable in the straight shaft so that the imaging array
extends into the pivotally attached tip. The straight shaft will
usually be rigid while the imaging core is relatively flexible,
allowing the imaging core to bend at the point where the tip is
pivotally attached to the shaft. In alternate embodiments, the
needle assembly may be attached directly to the ultrasound probe or
the imaging core may be hinged at the point where the tip is
pivotally attached to the shaft.
[0014] In certain preferred embodiments, the delivery needle will
carry a needle array having at least one tine which can be advanced
from the delivery needle, usually carrying a plurality of tines,
where the tines are reciprocatably attached to the delivery needle
to permit deployment and retraction, usually after the delivery
needle has been advanced into target tissue. A plurality of tines
will usually be arranged to radially diverge from the delivery
needle as the tines are distally advanced. Optionally, at least one
additional tine may be reciprocatably mounted on the delivery
needle in a range to be advanced axially from the needle, often
forming a center axis to a symmetric deployment of radially
diverging tines. In order to localize the treatment, the tines may
be electrically conductive while the delivery needle itself is
electrically non-conductive or insulating. In such cases, the tines
may be arranged to be connected to a single pole of an
electrosurgical power supply in order to provide for monopolar
treatment. Alternatively, a certain number of the tines may be
adopted to one pole of the power supply while others are connected
to the other pole, providing for bipolar treatment.
[0015] In certain exemplary embodiments, the imaging and
therapeutic delivery system will further comprise a handle attached
to the proximal end of the straight shaft. The handle may include a
lever coupled to the pivotally attached distal tip by one or more
pull rods. The lever can be pulled or pushed to actuate the pull
rod(s) to pivot the tip. Additionally, the handle may include a
first slide mechanism coupled to the delivery needle, where the
slide mechanism can be reciprocated to advance and retract the
needle along the axial path. In the embodiments which include the
plurality of tines, the tines may be reciprocatably attached to the
delivery needle and connected to a second slide mechanism on the
handle, optionally being disposed on the first slide mechanism
itself, to advance and retract the tines relative to the needle.
Optionally, a stop structure may be disposed on the pivotally
attached tip so that the stop structure prevents advancement of the
needle when the tip is parallel to the axial path of the
needle.
[0016] The present invention also comprises methods for treating
uterine fibroids. The methods include introducing a straight shaft
into the uterus. Uterine fibroids are then located using an
ultrasonic imaging transducer carried by or formed as part of a
pivotable tip attached to a distal end of the shaft. The tip is
pivoted to reposition a field of view of the ultrasonic transducer
carried by the tip. Optionally, the tip may block advancement of
the needle when disposed parallel to the shaft (prior to
deployment) and allow advancement when pivoted from the parallel
orientation. A delivery needle may be axially advanced from the
distal tip of the shaft into tissue near or in a uterine fibroid
located using the ultrasonic transducer. Advancement of the needle
may be observed by the transducer by aligning the field of view
with the needle advancement.
[0017] In preferred aspects of the methods of the present
invention, the shaft is introduced to the uterus via a transvaginal
and transcervical introduction. Locating fibroids may comprise
manually rotating and translating the shaft to scan the uterine
wall with the ultrasonic transducer. Locating may also comprise
pivoting the ultrasonic transducer to adjust the field of view.
Optionally, an array including a plurality of tines may be advanced
from the delivery needle after the needle has been advanced into
tissue at or near the uterine fibroid. This method will sweep the
ultrasound field of view relative to the needle and anatomy to be
imaged. The fibroid is then treated by delivering energy from the
needle and/or tines into the fibroid, typically radiofrequency
energy, including both monopolar and bipolar radiofrequency energy.
Usually, the tines will be electrically active to deliver the
radiofrequency energy while the delivery needle is electrically
non-conductive to limit the distribution of energy in the uterine
wall or other tissue being treated.
BRIEF DESCRIPTION OF THE DRAWINGS
[0018] FIGS. 1A and 1B are perspective views of an imaging and
therapeutic delivery system constructed in accordance with the
principles of the present invention shown with portions broken
away. In FIG. 1A, a delivery needle and array including radially
diverging tines are retracted within the shaft of the device, and a
pivotally attached tip is shown in axial alignment with the axial
deployment path of the needle. In FIG. 1B, the delivery needle and
associated tines are shown in their deployed configuration with the
pivotally attached tip shown oriented at an acute angle relative to
the axial advancement path of the needle.
[0019] FIG. 2 illustrates the imaging and therapeutic delivery
system of FIGS. 1A and 1B in cross-section. FIG. 2A is a detail of
the distal tip of the device illustrated in FIG. 2. FIGS. 2B and 2C
illustrate a stop structure on the pivotally attached tip which
prevents needle advancement prior to deployment of the tip.
[0020] FIGS. 3A and 3B illustrate the pivotal tip deployment
mechanism in detail, also in cross-section.
[0021] FIGS. 4A-4C illustrate the relative movement of the
deployment mechanism and the pivotal tip, as the deployment
mechanism is actuated.
[0022] FIGS. 5 and 6 are side and top views of the imaging and
therapeutic delivery system shown with portions broken away in a
non-deployed configuration.
[0023] FIGS. 7 and 8 are views similar to FIGS. 5 and 6, except
that the delivery needle has been deployed and the pivotally
attached tip has been positioned at an acute angle.
[0024] FIGS. 9 and 10 are views similar to FIGS. 5 and 6 and FIGS.
7 and 8, respectively, further illustrating the deployment of the
needle array, comprising radially diverging tines from the delivery
needle.
[0025] FIGS. 11A and 11B illustrate deployment of the delivery
needle and tines into tissue.
[0026] FIG. 12 illustrates a system without an ablation needle.
DETAILED DESCRIPTION OF THE INVENTION
[0027] Referring to FIGS. 1A and 1B, an imaging and therapeutic
delivery system constructed in accordance with the principles of
the present invention comprises a straight shaft assembly 12
including a hollow rod 14 and a needle tube 16. A tip 18 which is
adapted to receive an ultrasonic imaging array (shown in broken
line at 38) is pivotally attached to a distal end 20 of the hollow
rod 14 of the straight shaft assembly 12. A needle and tine array
21 (FIG. 1B) is deployed through a lumen or central passage in the
needle tube 16 at a distal end 20 of the shaft assembly 12. A
handle assembly 22 is attached to a proximal end 24 of the straight
shaft assembly 12 and includes a pivoting mechanism 26, typically
found on its lower surface as illustrated, for selectively pivoting
the imaging array tip 18 between a low profile configuration where
the tip 18 is axially aligned with the axis of the shaft assembly
12, as illustrated in FIG. 1A, and a deflected configuration where
the tip 18 is oriented at an acute or right angle relative to the
axis of the shaft, as illustrated in FIG. 1B. The tip 18 may be
placed in its axially aligned, low profile configuration for
introduction to the body cavity, for example through the cervix
into the uterus, and may be shifted to its deflected configuration
in order to image tissue and/or to track deployment of the
needle/tine array 21. As described in more detail below, the
pivoting mechanism 26 includes a lever 28 which may be manually
retracted from the distally advanced configuration shown in FIG. 1A
to the proximally retracted configuration shown in FIG. 1B in order
to pivot the tip 18.
[0028] The handle 22 will also include a delivery needle/tine
deployment mechanism 30 which includes a first slide subassembly 32
and a second slide subassembly 34. The handle will usually further
include a port 36 at its proximal end. Port 36 allows introduction
of an ultrasonic or other imaging core, where the imaging core has
an imaging array 38, typically an ultrasonic imaging array as
described in detail in copending application Ser. No. 11/620,594;
and parent application Ser. Nos. 11/564,164; and 12/973,587, the
full disclosures of which are incorporated herein by reference. The
proximal end of the handle will also allow electrical connections
to be made to the needle/tine array. Additionally, the distal end
of the handle will provide a standard luer connection for the
infusion of non-conductive coupling fluids.
[0029] Optionally, a stop structure 19 may be attached to an upper
surface of the pivotally attached tip 18, as illustrated in FIGS.
2B and 2C. When the tip 18 is parallel to the axis of the shaft
(hollow rod 14), the stop structure 19 will block the advancement
path of the needle 16 (as shown in FIG. 2B). This is advantageous
since it prevents accidental needle advancement while the shaft
assembly 12 is in the introductory configuration. Deployment of the
tip 18, as shown in FIG. 2C, moves the stop structure 19 out of the
advancement path of the needle 16, as described below.
[0030] Referring now to FIGS. 2, 2A, 3A, and 3B, operation of the
pivot mechanism 26 for selectively deflecting the tip 18 disposed
at the distal end of the straight shaft assembly 12 will be
described. For clarity, components of the first slide assembly 32
and second slide assembly 34 have been removed from the view in
FIG. 2. The tip 18 is pivotally attached at the distal end 20 of
the straight shaft assembly 12 by a pivot pin 40 or similar
structure, as best seen in FIG. 2A. A pair of pull rods 42 are
attached at anchors 44 so that drawing the wires in a proximal
direction will deflect the tip 18 from an axially aligned
configuration, as shown in broken line in FIG. 2A, to the deflected
configuration, as shown in full line in FIG. 2A. The rods 42 extend
through tubes 46 disposed on each side of the hollow rod 14 of the
shaft assembly 12. As best seen in FIGS. 3A and 3B, the rods 42 are
attached at their proximal ends to a rotating anchor 50 disposed in
lever 28. Thus, by drawing the lever 28 proximally, as shown in
FIG. 3A, the tip 18 may be laterally deflected, as shown in full
line in FIG. 2A. Conversely, by pushing the lever 28 in a distal
direction, as shown in FIG. 3B, the tip 18 may be returned to the
axially aligned configuration as shown in broken line in FIG. 2A.
The lever 28 is pivotally attached to the body of handle 22 by a
pivot pin 48 so that the anchor 50 is offset from the point of
rotation of the lever 28. Thus, the anchor 50 is actually
translated as the lever is rotated back and forth about the pivot
pin 48.
[0031] A locking pin 52 allows the lever 28 to be selectively
locked in place to hold the pivot tip 18 in a fixed orientation.
Locking pin 52 is mounted in a central passage 54 of the lever 28
and carries a pin 56 which seats in one of a plurality of pockets
58 formed in an arcuate locking strip 60. Thus, the lever 28 can be
released by pressing the pin 52 against spring 62 so that the pin
56 is lifted out of the pocket 58, as shown in FIG. 3A. In this
configuration, the lever may be moved freely back and forth to
deploy the tip 18. When the tip 18 is in its desired location, the
locking pin 52 may be released to permit pin 56 to engage the
closest pocket 58 where it is held in place by spring 62. It will
be appreciated that the lever 28 will typically be advanced
forwardly to close the tip 18 to a low profile configuration for
introducing the imaging and therapy delivery system 10 to the
patient for treatment, for example through the cervix into the
uterus. Once in place, the lever 28 can be unlocked using the
locking pin 52 and oriented to a desired angle relative to the
shaft assembly 12 to permit imaging and, in particular, to allow
advancement of the delivery needle 70 in the tissue to be
observed.
[0032] Referring now to FIGS. 4A-4C, use of the lever 28 for
deflecting the tip 18 is illustrated. Initially, the tip 18 is
axially aligned with the axis of the shaft assembly 12 and the
lever 28 is in its forward or distal-most position, as shown in
FIG. 4A. By depressing locking pin 52, as shown in FIG. 4B, lever
28 may be drawn proximally as indicated by the adjacent arrow, to
deflect the tip 18 away from the axis of shaft 12, as shown by the
arrow adjacent the tip in FIG. 4B. When the lever 28 reaches its
fully proximal position, as shown in FIG. 4C, the tip 18 has been
fully deflected away from the axis of shaft assembly 12. Note that
slide subassemblies 32 and 34 (for extending delivery needle 70 and
needle array 21) have not been activated in FIGS. 4A-4B.
[0033] Referring now to FIGS. 5-10, operation of the first slide
subassembly 32 and the second slide subassembly 34 will be
described. For clarity, portions of the pivot mechanism 26 have
been removed from these views. Prior to deployment, as shown in
FIGS. 5 and 6, the needle/tine array 21 is fully drawn into the
central passage of needle tube 16. Needle tube 16 has an open
distal tip 64 through which the delivery needle and tines will
emerge when advanced using the slide subassemblies 32 and 34.
[0034] The first slide subassembly 32 comprises a reciprocating
carriage 66 having a coupling 68 attached to a proximal end of the
needle 70. The carriage 66 may be axially advanced and retracted by
manually pressing buttons 72 to disengage pins 74 (FIG. 5) from
pockets 76 in a straight locking strip 78. Once the pins 74 are
disengaged, the carriage 66 may be distally advanced, as shown in
FIGS. 7 and 8, to advance tip 80 of needle 70 from the distal end
of the needle tube 16. The buttons 72 may then be released to allow
pins 74 to reenter the adjacent pockets 76 in the locking strip 78,
thus locking the needle 70 in place.
[0035] Referring now in particular to FIGS. 9 and 10, a plurality
of radially diverging tines 82 may be deployed from the distal end
of needle 70 using the second slide subassembly 34 which includes a
thumb slide 84. The thumb slide 84 is reciprocatably carried in the
carriage 66 so that the thumb slide will advance the tines relative
to the needle. The thumb slide is connected to a tine rod 86 which
enters a hollow central passage or lumen of the needle 70 and is
coupled to the plurality of tines 82 so that advancement of the
thumb slide 84 from the retracted position shown in FIGS. 7 and 8
to the distally advanced position shown in FIGS. 9 and 10 causes
the tines 82 to emerge from the distal end of the needle 70. The
tines 82 are preferably formed from a straight, resilient metal,
such as stainless steel, nickel titanium, or the like, and are
deflected outwardly by ramps (not shown) in the distal end of the
needle. Optionally, a lockout circuit (not shown) may be provided
to prevent energizing the tines if the tines are not fully
advanced.
[0036] The use of the imaging and therapeutic delivery system 10 of
the present invention is illustrated in FIGS. 11A and 11B. After
imaging using the imaging array 38 carried on or in tip 18, the
needle 70 is advanced into target tissue identified by the imaging
using the first slide subassembly 32, as shown in FIG. 11A.
Usually, the position of the tip 18 will be adjusted to assure that
travel of the needle 70 into the tissue may be observed. After the
location of the needle tip 80 has been confirmed, the thumb slide
84 of the second slide subassembly 34 may then be advanced, as
shown in FIG. 11B, to extend the tines 82 into the tissue. In the
preferred embodiments of the present invention, the needle 70 and
tines 82 will be rotatably connected to the remainder of the device
to allow the handle to be rotated, thus rotating the imaging array
38, to facilitate imaging even after the needle and tines have been
deployed.
[0037] Referring now to FIG. 12, a delivery system 110 without an
ablation needle is illustrated. A deflectable distal tip 126 of the
rigid shaft 116 may be deflected by the use of pull or tensioning
wire(s) housed within the shaft 116. Deflection may occur at a true
mechanical pivot or at a flexible zone at the shaft distal end 118.
As discussed above, when the delivery shaft 116 is deflectable by a
user, various needles may be used to match the amount of deflection
provided by the distal tip 126 as well as the amount of tilt
provided by the ultrasound array 112. Hence, a needle guide 144
will typically be empty until the distal end 118 of the shaft 116
is deflected. For example, the shaft 116 may be inserted in a
straight configuration. The distal tip 126 may then be deflected
until a target anatomy is identified. A needle is then back loaded
within the guide passage 170 that corresponds to the amount of the
deflection.
[0038] Table I below illustrates possible viewing angles .kappa.
that may be achieved by the cumulative effects of the shaft bending
angle .beta. (e.g., either through active deflection of the distal
tip or a pre-shaped or pre-bent distal tip) and the ultrasound
tilting angle .alpha.. The matching needle angles .theta. based on
the possible viewing angles .kappa. are further illustrated. In
example 1, the shaft 116 is in a straight configuration so that the
viewing angle .kappa. is provided solely by the tilting angle
.alpha. of the ultrasound array 112. In example 4, the needle 114
will have a straight configuration. In example 5, a non-tilted and
non-bent ultrasound array 112 version is covered. It will be
appreciated that the viewing angle .kappa. will be more than the
bend angle .theta. of the shaft 116 due to the additive effect of
the tilting angle .alpha. of the ultrasound array 112. This allows
the bend on the distal tip 126 of the shaft 116 to be shallower
without compromising the cumulative viewing angle .kappa., which is
of particular benefit for patient insertion considerations. In the
case of a deflectable distal tip 126 in which insertion may be
implemented in a straight configuration, the tiled ultrasound angle
.alpha. still aids in reducing the needle angle .theta..
TABLE-US-00001 TABLE I Viewing Angle Tilt Angle Bend Angle Needle
Angle Example (.kappa.) (.alpha.) (.beta.) (.theta.) 1
7.degree.-10.degree. 7.degree.-10.degree. 0.degree. 80.degree. 2
20.degree. 7.degree.-10.degree. 10.degree.-13.degree. 70.degree. 3
45.degree. 7.degree.-10.degree. 35.degree.-38.degree. 45.degree. 4
90.degree. 7.degree.-10.degree. 80.degree.-83.degree. 0.degree. 5
0.degree. 0.degree. 0.degree. 90.degree.
[0039] While the above is a complete description of the preferred
embodiments of the invention, various alternatives, modifications,
and equivalents may be used. Therefore, the above description
should not be taken as limiting the scope of the invention which is
defined by the appended claims.
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